Top Ten Things You Need to Know About HBOT #1: Two New HBOT Indications

In the tenth and final article in a series, this review article will discuss and give updates on top ten things we need to know about hyperbaric oxygen therapy (HBOT).
 

1

Did you know that the FDA just approved 2 new indications for HBO therapy?                    

The Food and Drug Administration (FDA) updated its statement on HBOT as of July of 2021 to reflect 14 indications for which HBOT has been cleared.¹

Idiopathic sudden sensorineural hearing loss and central retinal artery occlusion were both approved as indications by the Undersea and Hyperbaric Medical Society (UHMS) and the American College of Hyperbaric Medicine (ACHM) in 2011, but the FDA only recently approved these two indications in 2021.
 
The FDA has approved HBOT for the following conditions (new indications in bold):
 
    1.    Air embolism
    2.    Severe anemia
    3.    Acute thermal burn injuries
    4.    Carbon monoxide poisoning
    5.    Crush injury, compartment syndrome, and related acute traumatic ischemias
    6.    Decompression sickness
    7.    Gas gangrene
    8.    Osteomyelitis
    9.    Radiation injury (soft tissue and bone)
    10.    Compromised skin grafts and flaps
    11.    Enhancement of healing of chronic/problem wounds
    12.    Intracranial abscess
    13.    Idiopathic sudden sensorineural hearing loss
    14.    Treatment of central retinal artery occlusion
 
Idiopathic sudden sensorineural hearing loss (ISSHL) is defined as a loss of hearing of at least 30 decibels that occurs over at least three consecutive frequencies and lasts at least 3 days, without a known etiology.¹ Symptoms associated with ISSHL include tinnitus, vertigo, and aural fullness.² In patients with ISSHL, perilymph oxygen tension is decreased significantly. This alters the arterial-perilymphatic oxygen concentration difference. This is important to note, because tissue oxygenation to the structures within the cochlea happens via diffusion of oxygen from capillary networks in the cochlea into the perilymph and cortilymph.
 
With the help of HBOT, arterial-perilymphatic oxygen concentration differences can remain high by maintaining a consistently high perilymph oxygen concentration. Patients who present within 14 days of symptoms onset should be considered for HBOT, as early intervention has been associated with better outcomes.³ HBOT for ISSHL should be administered at 2.0–2.5 ATA for 90 minutes, daily, for a total of 10–20 treatments. Patients who fail to improve within the first ten treatments are likely to not benefit from further treatments.¹
 
Central retinal artery occlusion (CRAO) is an ophthalmological emergency characterized by the sudden and painless loss of vision. The most common cause of CRAO is embolism, making this condition comparable to that of a stroke with the difference being the location.⁴ CRAO leads to hypoxia and retinal tissue is especially sensitive and intolerant to hypoxic conditions, as it has the highest oxygenation consumption rate of any organ in the body.⁵ In selecting the optimal candidate for HBOT, the clinician must take careful consideration to initiate therapy before retinal tissue is irreversibly damaged. Other factors that can potentially affect the outcome of HBOT on CRAO include the degree of occlusion of the vessel and the level of the occlusion at the vessel. An adequate oxygen partial pressure must be maintained until circulation is restored in other to preserve retinal tissue.⁶
 
The patient should be referred for HBO therapy if there is no response to surface oxygen at highest FiO₂ for 15 min. HBOT can be delivered for 90 minutes at the depth of return of vision, with a maximum of a USNTT⁶ for the first treatment. Repeat treatments 2–3 times daily may be necessary until the angiogram normalizes or the patient has no further improvement for three treatment.⁹

Summary

HBOT is well accepted modality of treatment for many approved indications. The Centers for Medicare and Medicaid Services (CMS) have approved undersea and hyperbaric medicine as an approved specialty that all full-time wound care and hyperbaric medicine doctors can choose as their primary specialty. HBO therapy research continues for its use of other conditions including, but not limited to, some neurological indications such as traumatic brain injuries as reported by a recent metanalysis by Harch.⁷
 
With increasing interest in HBO therapy and more centers opening, the FDA has made a statement that “If your healthcare provider recommends HBO therapy, the FDA advises receiving the treatment at a hospital or a facility that has been inspected and is accredited by the UHMS.”⁸
                                                     
Denise Nemeth is a second-year medical student at the University of the Incarnate Word School of Osteopathic Medicine in San Antonio, TX. Formerly a general and vascular surgery PA in a rural community, Ms. Nemeth aspires to become a general surgeon. She is certified wound specialist with the American Board of Wound Management. Her interests include rural health, wound healing, colorectal surgery, and minimally invasive surgery.
 
Jayesh B. Shah is Immediate Past President of the American College of Hyperbaric Medicine and serves as medical director for two wound centers based in San Antonio, TX. In addition, he is president of South Texas Wound Associates, San Antonio. He is also the past president of both the American Association of Physicians of Indian Origin and the Bexar County Medical Society and Current of Board of Trustees of Texas Medical Association.    

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References
 
1. Murphy-Lavoie HM MM. Hyperbaric treatment of sensorineural hearing loss. In: StatPearls [internet]. Treasure Island (FL): StatPearls Publishing; 2022.
2. Anyah A, Mistry D, Kevern E, Markiewicz K. Idiopathic sudden sensorineural hearing loss: Average time elapsed before presentation to the otolaryngologist and effectiveness of oral and/or intratympanic steroids in late presentations. Cureus. 2017;9(12):e1945. doi: 10.7759/cureus.1945 [doi].
3. Piper SM, LeGros TL, Murphy-Lavoie H. 14. idiopathic sudden sensorineural hearing loss (New! Approved on October 8, 2011 by the UHMS board of directors). Undersea and Hyperbaric Medical Society.
4. Soares A, Gomes NL, Mendonça L, Ferreira C. The efficacy of hyperbaric oxygen therapy in the treatment of central retinal artery occlusion. BMJ Case Rep. 2017;2017:10.1136/bcr-220113. doi: bcr-2017-220113 [pii].
5. Hanley ME, Hendriksen S, Cooper JS. Hyperbaric treatment of central retinal artery occlusion. In: StatPearls [internet]. Treasure Island (FL): StatPearls Publishing; 2022.
6. Undersea and Hyperbaric Medical Society. 06a. arterial inefficiencies: Central retinal artery occlusion.
7. Harch PG. Systematic review and dosage analysis: Hyperbaric oxygen therapy efficacy in mild traumatic brain injury persistent postconcussion syndrome. Front Neurol. 2022;13:815056. doi: 10.3389/fneur.2022.815056 [doi].
8. U.S. Food and Drug Administration. Hyperbaric oxygen therapy: Get the facts. https://www.fda.gov/consumers/consumer-updates/hyperbaric-oxygen-therapy-get-facts. Updated 2021.
9. Murphy-Lavoie H, Butler F, Hagan C. Chapter 2A, Arterial insufficiencies, Central Retinal Artery Occlusion, UHMS HBO indications 14th Edition. Moon RE (ed.), Best Publishing, 2019.